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FDA 510(k)

HOLLOW FIBER DIALYZER, BIO CARE PS 130

K-Number: K900018 · 1990-07-27

ApplicantNational Medical Care, Medical Products Div., Inc.
Decision Date1990-07-27
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HOLLOW FIBER DIALYZER, BIO CARE PS 130 is the device name listed in this FDA 510(k) record. The listed applicant is National Medical Care, Medical Products Div., Inc.. It received FDA 510(k) clearance on 1990-07-27 under 510(k) number K900018. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HOLLOW FIBER DIALYZER, BIO CARE PS 130?

HOLLOW FIBER DIALYZER, BIO CARE PS 130 is a medical device that received FDA 510(k) clearance on 1990-07-27. The listed applicant is National Medical Care, Medical Products Div., Inc.. The 510(k) number is K900018.

When did HOLLOW FIBER DIALYZER, BIO CARE PS 130 receive FDA 510(k) clearance?

HOLLOW FIBER DIALYZER, BIO CARE PS 130 received FDA 510(k) clearance on 1990-07-27, under 510(k) number K900018.

Who is the listed applicant for HOLLOW FIBER DIALYZER, BIO CARE PS 130?

The FDA 510(k) record lists National Medical Care, Medical Products Div., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HOLLOW FIBER DIALYZER, BIO CARE PS 130?

The FDA product code for HOLLOW FIBER DIALYZER, BIO CARE PS 130 is KDI.

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Other records listing National Medical Care, Medical Products Div., Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K962081COMBILINES HEMODIALYSIS BLOOD TUBING SETK941757FORMALIN REUSE CARTK952343FOCUA 90R, 90HR, 120R, 120HR, 160R, 160HR HOLLOW FIBER DIALYZERK930843RAPID DISCONNECT Y-SET, CAT. NO. 48-7000K914790HOLLOW FIBER DIALYZER FOCUS 9OR/90H-R/120R/120H-RK920697DEXTROLYTE II PERITONEAL DIALYSIS 48-3029-7 CLAMP

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Related Devices (Code: KDI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261267Careflux H60;Careflux H70;Careflux V500Fresenius Medical Care Renal Therapies Group, LLCK252377NxStage System One with NxViewFresenius Medical Care Renal Therapies Group, LLCK260533ELISIO™-HNipro Medical CorporationK252459multiFlux 130 (F00013123); multiFlux 160 (F00013124)Fresenius Medical Care Renal Therapies Group, LLCK253412Tablo Hemodialysis System (PN-0008000, PN-0006000U)Outset Medical, Inc.K253518FX CorAL 40; FX CorAL 50Fresenius Medical Care Renal Therapies Group, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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